Elisabeth Quoix, M.D., from the Université de Strasbourg in France, and colleagues assessed TG4010 in combination with first-line chemotherapy in advanced NSCLC. In this phase 2B study, 148 patients with advanced NSCLC expressing MUC1 by immunohistochemistry were allocated to two treatment groups: 74 patients received TG4010 in combination therapy with cisplatin and gemcitabine repeated every three weeks for up to six-cycles, and 74 patients in the control group received the same chemotherapy without TG4010. Six-month PFS with target rate of 40 percent or higher in the experimental group was the primary end point.

The investigators found that the six-month PFS was 43.2 and 35.1 percent in the TG4010 and control groups, respectively. Adverse events (fever, abdominal pain, and any grade injection-site pain) were more common in the TG4010 versus control groups. The most common grade 3 to 4 adverse events were neutropenia and fatigue, which were more common in patients in the TG4010 group than in the chemotherapy alone group (45.2 versus 43.1 percent and 24.7 versus 18.1 percent); and anorexia (4.1 versus 13.9 percent) and pleural effusion (none versus 5.6 percent) were significantly more common in the chemotherapy alone group. At least one serious adverse event was found in 52.1 and 47.2 percent of the patients in TG4010 and chemotherapy groups, respectively.